NSF International Maximum Allowable Level per Serving Applies to All Drugs in NSF Certified for Sport® Testing Menu

Originally Published – March 2, 2018

It is good to see NSF International engaging in the important discussion on whether it is appropriate to utilize maximum allowable levels per serving (MALs) for banned substances in dietary supplements, as they have recently admitted doing. We appreciate that NSF has now recognized this policy as inappropriate and is working to adjust it. Issues, however, remain.

The latest NSF International statement released February 27 (http://www.nsfsport.com/news-resources/news/nsf-certified-sport-products-no-doping-risk-athletes-consumers.php) was offered “in the spirit of transparency.” It asserts that MALs are only used “with some substances that are naturally occurring in plants and animals (like GHB and androstenedione).” What athletes need to understand, as do the nutritionists, dieticians, coaches, trainers and other stakeholders that rely upon NSF as a means of protection, is that NSF’s own documentation demonstrates that NSF has been using MALs for all 270 substances on the NSF Certified for Sport® testing menu.

Strikingly, NSF’s statement admits: “While the MALs were intended to apply to those few substances that are naturally occurring in plants and animals, we’ve learned that in some cases these MALs have been applied to banned substances that are not naturally occurring. As a result, in some instances products that contain athletic banned substances that are not naturally occurring have been certified when detected below the MALs.” For a company that portrays itself as the best form of protection for athletes, this is a startling admission.

Let’s be clear on the problem. NSF has a reporting level, and banned drugs are reported above that level. However, NSF allows drugs to be present up to their second threshold, the maximum allowable level per serving. NSF’s February 27th statement characterizes this as a higher detection level, but this is not accurate and seems an attempt to obfuscate facts and confuse people. As we demonstrated in our follow-up, the NSF 306-2016 Certification Guideline clearly defines and distinguishes the difference between a report threshold and a maximum allowable level per serving.

Plainly put, NSF International policies have permitted performance-enhancing drugs to be present in NSF Certified for Sport® products above report thresholds and below MALs. No other third-party certification provider operates like this, except in isolated situations where ingredients may naturally contain banned substances in small amounts.

The authors and contributors who recently exposed NSF’s ill-advised practices reject the notion that their pieces contained “inaccurate information about NSF’s Certified for Sport® program” as NSF’s earlier statement (http://www.nsfsport.com/news-resources/news/banned-substances-not-permitted-nsf-certified-for-sport.php) and the latest one allege. Quite the opposite, our articles quote language directly from NSF materials to ensure truthfulness and transparency. The latest NSF statement admits that, “MALs for banned substances have been applied too broadly,” and now focuses on whether the practices pose a doping risk to athletes.

NSF International Maximum Allowable Levels Present a Doping Risk to Athletes

NSF’s MALs practices are clearly defined in their technical notes: “Maximum allowable level per serving has been determined based on consideration of the urine concentration necessary to be perceived as a risk to an athlete based on World Anti-Doping Agency (WADA) thresholds and the per serving limit was set in order to effectively eliminate that risk.”

NSF International acknowledges now that “in some instances products that contain athletic banned substances that are not naturally occurring have been certified when detected below the MALs.” NSF says these “very low levels of banned substances do not present a doping risk to athletes and consumers.” But has this claim been conclusively established for each individual drug through an excretion study among a representative population? If not, why would an athlete accept the inherent risk when for some drugs parts per trillion amounts found in urine could lead to a doping violation?

The NSF statement explains that the company is setting out to fix this alarming practice by “updating our internal procedures to make sure MALs are only used when evaluating test results for substances that are naturally occurring in food.” Why change the procedures if there is no risk?

Not wanting to wait for an athlete to test positive to demonstrate our concern, we felt it was necessary to proactively address the risk involved with the MALs. The MALs risk is compounded by misrepresentation of the word all in NSF International databases, which implies that testing applies to every finished product batch when in reality only a subset of batches or annual testing may have occurred.

Dubious Definition of ‘All’ Used in NSF Certified for Sport® Database

NSF International’s recent statement glossed over the second issue raised in our original piece, namely the misuse of the word all. Unfortunately, they provided no real explanation as to the percentage of batches tested or the frequency of testing that the word all represents.

The NSF 306-2016 Certification Guideline includes an “All Lots Designation” option that “approximately 8 percent of manufacturers producing Certified for Sport® supplements are able to” qualify to use. This number appears small, but included in this 8% are some rather large brands with worldwide circulation, so this 8% is certainly not an insignificant number.

The word all is commonly defined as 1) the whole amount, quantity, or extent of; 2) every member or individual component of. But that is not what it means when you see it in the NSF Certified for Sport® database. We quoted their exact definition of the word all from the NSF 306-2016 Certification Guideline previously. In the NSF Certified for Sport® database, all apparently could mean that only a subset of finished product batches has been tested, leaving others unprotected.

The new NSF statement fails to provide an accounting of how they really define the word all in practice. Does it 1) equate to NSF discretion without any specifics, or 2) does NSF still use the formula approach from the NSF Certified for Sport® Guideline 306-06 (quoted in the original article) that allows anywhere from 2.6% to 30% to 100% of finished product batches to be tested?

Questionable Use of the Word ‘All’ in the NSF/ANSI 173 Database

We note that NSF repeatedly mentions the “NSF/ANSI 173 American National Standard for Dietary Supplements” in their clarification. This standard was developed by NSF International and designated as an American National Standard by the American National Standards Institute (ANSI). While we support standardization in dietary supplement quality control, we find NSF’s application of this standard troubling as it is polluted by questionable use of the word all in the NSF/ANSI 173 database.

The NSF/ANSI 173 database (http://info.nsf.org/Certified/Dietary/Listings.asp?StandardExt=&TradeName=&CompanyName=&PlantCountry=&ProductType=&search=Search) lists products that participate in the NSF Contents Tested & Certified program for label verification and contaminant testing. But the NSF/ANSI 173 database suffers from the same confusing definition of the word all exhibited in the NSF Certified for Sport® database. In the NSF/ANSI 173 database every single product is listed using the word “All” under “Product ID.” But the minimum requirement for this certification is annual testing. So, in this database the word all could mean annual? If so, why not just say that? That is what transparency is all about.

Sound Practices and Transparency are Essential to Third-Party Certification

Attempting to calculate maximum allowable levels per serving for all drugs on the WADA Prohibited List, and redefining the word all, is like playing with fire in our view. At some point an athlete will get burned. That is why we brought the concerns forward in the first place. Such practices could put athletes at risk, and that seems a likely reason why NSF has stated they are changing the MALs procedures.

NSF International says they “endeavor to remain transparent,” but their response and clarification have not demonstrated that commitment. As we pointed out previously, the NSF Certified for Sport® testing menu, with the MALs noted, used to be available through a small link but that disappeared in a recent website update. Perhaps this will be made publicly available again in the future so that stakeholders can evaluate the adjustments NSF makes to the MALs policy. Perhaps the word all will be clearly defined in product databases in the future.

We have started a discussion that seems to be leading to important changes. Our goal is to help protect stakeholders and to improve quality control in the dietary supplement and nutrition industry and make it more transparent. Athletes and consumers deserve nothing less.

Authors:

Oliver Catlin, BSCG President & Co-founder
Email: info@bscg.org

Douglas S. Kalman, PhD, RD, FACN.
Adjunct Professor, Sports Nutrition. College of Healthcare Sciences.
Nova Southeastern University. Davie, FL.
Email: dkalman@nova.edu

Supporting Contributors:

Susan Kleiner, PhD, RD, FACN, CNS, FISSN.
Owner, High Performance Nutrition, LLC, Mercer Island, WA.
Email: susan@drskleiner.com

Don H. Catlin, M.D.
Founder and former Director, UCLA Olympic Analytical Laboratory,
BSCG Chief Science Officer & Co-founder
Email: info@bscg.org

Ryan Connolly, BSCG Counsel & Co-founder
Email: info@bscg.org